Regulatory Project Manager

We are growing our Regulatory Project Management team, and we'd love to connect with experienced, proactive US-based Regulatory Project Managers.

These home-based roles are exciting opportunities to play a crucial role in driving regulatory success for our biotech clients while contributing to our company's growth.

In these pivotal roles, you will:

Oversee the operational execution of diverse regulatory projects

Ensure timely delivery of high-quality regulatory submissions

Contribute to long-term strategic planning for the clients’ regulatory initiatives

Be responsible for managing project scope and budget

Identify and mitigate potential risks while maintaining strict regulatory compliance

Collaborate closely with the clients’ teams and internal stakeholders

Drive continuous improvement in regulatory processes and methodologies

Facilitate interdisciplinary meetings as the main client and internal contact, as well as the FDA’s liaison, representing our sponsors as US Agent, as requested

Build client relationships, gain new and repeat business

The ideal candidates will bring:

Strong background in regulatory affairs and project management

Excellent organizational skills

Proven track record of successful regulatory submissions

Previous experience creating and updating project timelines

Excellent leadership, communication and stakeholder management skills

Ability to adapt to client-specific processes and culture

Prompt communication and a strong understanding of work prioritization and urgencies

Excellent customer service skills

Proactive approach to problem-solving and risk mitigation

Foreign language skills are a plus with fluency in Japanese, Chinese, or Korean highly preferred

Qualifications:

Bachelor's degree in a relevant scientific field; advanced degree (PharmD, PhD, or equivalent) preferred.

Minimum of 3+ years in a regulatory affairs related project management role.

Demonstrated track record of successfully leading global regulatory projects and achieving key milestones.

In-depth knowledge of global regulatory requirements and processes across various therapeutic areas.

Strong strategic thinking skills with the ability to translate regulatory insights into business opportunities.

Excellent project management skills, including the ability to manage multiple complex projects simultaneously.

Outstanding communication and interpersonal skills, with the ability to influence and collaborate effectively across all levels of the organization.

Proven leadership abilities, including experience in mentoring and developing team members.

Adaptability and resilience in navigating changing regulatory environments and organizational priorities.

Ideally candidates will be located in EST. Consideration, however, will be given to experienced Regulatory Project Managers within other US time zones who have the ability to work EST hours.

These roles offer the opportunity to partner with multiple clients and make significant contributions to their regulatory programs and, ultimately, providing new and/or better treatment options to patients. Plus, you'll be part of a growing team with potential for career advancement.

If you're ready to take on a challenging role that combines your regulatory expertise with strong project management skills in a client-focused environment, we want to hear from you. Join us in shaping the future of regulatory affairs and making a lasting impact on global healthcare through effective strategy and execution.

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